News about supervision and inspection of pharmaceutical companies
New criteria for the notification of medicines supply shortages
| 06 June 2023 |
The Danish Medicines Agency has established new criteria for when companies must notify medicines supply shortages. The new criteria make it easier for the companies to know when and for which medicinal products they must notify supply shortages, and a new form has made notification even easier.
Change of practice for the Danish Medicines Agency’s inspections
| 04 November 2022 |
The Danish Medicines Agency is now implementing the digital signing system called Penneo. As of 1 November 2022, we will be using digital signatures to sign all inspection reports.
Extraordinary measures for clinical trials due to COVID-19
| 09 October 2020 |
UPDATED. We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.
Danish Medicines Agency increases communication on medicine supply
| 24 June 2020 |
The Danish Medicines Agency reinforces the communication about the supply of medicines in Denmark through announcements that will be sent out when supply problems are expected to have therapeutic consequences for the patients.
Clarification on companies’ notification of supply problems to the Danish Medicines Agency
| 01 April 2020 |
The Danish Medicines Agency would like to clarify when and how companies must notify the Danish Medicines Agency of any supply problems they might experience.
Safer prescription of blood thinning agents
| 04 September 2018 |
A collaboration between pharmaceutical companies, pharmacies and authorities has eliminated a common cause of dosing errors involving blood thinning agents.
Recall of valsartan blood pressure medicine
| 10 August 2018 |
Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible in order to to be switched to another type of medicine.
Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 01 August 2017 |
German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.
Counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 27 July 2017 |
One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.
More batches of EpiPen® are withdrawn
| 06 April 2017 |
MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.
Withdrawal of a batch of EpiPen® 300 micrograms
| 17 March 2017 |
MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.
EuropharmaDK regains its authorisation
| 13 March 2017 |
The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.
New transatlantic agreement on mutual recognition of inspections
| 03 March 2017 |
The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.
Update on Europharma DK
| 03 February 2017 |
Europharma DK can now legally sell medicines repacked and released by Abacus Medicine.
Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products
| 03 January 2017 |
Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).
Experts for the European Pharmacopoeia's groups of experts and working parties
| 07 October 2016 |
A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.